Identity
- Trade Name
- Lower Body Ultium Motion Strap Set EUDAMED
- Device Name
- Wireless IMU Family Accessories EUDAMED
- Model / Reference
- 874Z EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00816271021145 EUDAMED
- Basic UDI-DI
- 081627102IMUACC5F EUDAMED
- Direct Marketing DI
- 00816271021145 EUDAMED
- EMDN Code
- Z12062599 KINEMATIC MOTION CAPTURE ANALYSIS SYSTEMS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Lower Body Ultium Motion Strap Set by Noraxon USA, Inc. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 081627102IMUACC5F | Class I | Active |
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Manufacturer
- Manufacturer
- Noraxon USA, Inc.
- EUDAMED SRN
- US-MF-000003882
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED 7e0e6ee0-88eb-442e-8170-50f3b0c25b9a 61 fields · synced Jul 21, 2026